CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01265992
NCT01265992N/ACompleted

Post Marketing Observational Study to Assess Patient Management Practices and Quality of Life With the Capsules Form of Paricalcitol in the Treatment of SHPT in Stage 3 - 5 Chronic Kidney Disease Patients Not Yet on Dialysis Under Conditions of Usual Clinical Care (CAPITOL)

AbbVie (prior sponsor, Abbott)·observational·Posted Dec 24, 2010·Updated Feb 19, 2014

In Brief

An observational study for Secondary Hyperparathyroidism and Chronic Kidney Disease. Completed, enrolled 50 participants across 10 sites.

Detailed Summary

Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 \& 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden. This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSweden

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2010
Enrollment StartFeb 1, 2011
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.5 years ago